Patient Monitor ICP Interface Cable Instructions for Use Rev E

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EN – ENGLISH

Codman® Patient Monitor Interface Cable IMPORTANT INFORMATION Please Read Before Use

Description

The Patient Monitor Interface Cable (Interface Cable) is intended for use as a connecting cable between the recommended DirectLink® (REF 82-6828) or CereLink™ (REF 82-6820) ICP Monitor and selected patient bedside monitor (available from third party suppliers). The Interface Cable is 2.5m long, is reusable and is supplied nonsterile. The cable can be wiped down before each use and is compatible with the following: • •

Combination wipes (Quaternary Ammonium/Isopropyl Alcohol) 70% Isopropyl Alcohol

CAUTION: Do not immerse an Interface Cable in any liquid or allow liquid to enter the connectors. Do not use an Interface Cable if the connectors become wet; erratic results may occur. CAUTION: Use an Interface Cable only with the patient bedside monitors labeled on the packaging and listed below, and corresponding to the catalog number on the cable. Using an Interface Cable with other patient bedside monitors may cause a malfunction.

Reordering Information

The Interface Cable is intended for use with select patient bedside monitors, as shown in the table below: Product Name

Cable Length

Catalog Number

Dräger/Siemens (10 pin)

2.5 meters

82-6880

Philips (12 pin)

2.5 meters

82-6881

GE (11 pin)

2.5 meters

82-6882

Spacelabs (6 pin)

2.5 meters

82-6883

GE Datex-Ohmeda

2.5 meters

82-6884

Dräger/Siemens (7 pin)

2.5 meters

82-6880 with adapter from Dräger

Nihon Koden (12 pin)

2.5 meters

82-6887 with adapter from Nihon Koden

Nihon Koden (5 pin)

2.5 meters

82-6887

Fukuda Denshi DS-800

2.5 meters

82-6888

Fukuda Denshi DS-7000

2.5 meters

82-6889

Any serious incident that has occurred in relation to the device for the user and/or the patient should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established.

WARNING

The Interface Cable is MR Unsafe. Do not bring the Interface Cable into the MR environment. Modification of the Interface Cable is not permitted. Unauthorized modifications can cause a malfunction resulting in serious patient injury.

Precautions

Read and follow the instructions packaged with the ICP Monitor and the patient bedside monitor before using an Interface Cable. Visually inspect the Interface Cable before each use for the following: • • •

Interface cable insulation is intact and no cracks are visible Connectors are undamaged; connector pins are not bent Connectors are completely dry

CAUTION: If the Interface Cable does not comply with these conditions, or has any other problems that might affect function, do not use it. Contact your sales representative for a replacement. 2

EN – ENGLISH Ensure you are connecting the Interface Cable to the patient bedside monitor interface connection on the ICP Monitor. The connectors for the Interface Cable must be properly aligned with the receptacles on the ICP Monitor before pushing these parts together. DO NOT twist the cable connector. Twisting the connector will damage the pins and can lead to product malfunction.

Electrostatic Discharge (ESD) Information

Although the Interface Cable is not itself subject to electrostatic discharge (ESD), the ICP Sensor (a system component) is subject to ESD and could be damaged during a discharge. Please read this important information. CAUTION: Exposure to electrostatic discharge (ESD) energy could damage the Sensor. High levels of ESD could damage the electronic components and cause the Sensor to be rendered inaccurate or inoperable. Take all precautions to reduce the buildup of electrostatic charge during the use of this product. • • •

Provide patient grounding; e.g., grounding straps on gurneys Avoid the use of materials that could generate ESD during patient movement and transport; e.g., nylon transfer boards with bedding Before touching the patient, caretakers should discharge ESD buildup by touching a grounded metal surface, such as a bed rail

It is recommended that all hospital personnel in contact with these devices receive an explanation of the ESD symbol and training in ESD precautionary procedures. Training should include, at a minimum, an introduction to electrostatic discharge, when and why it occurs, precautionary measure, and the damage that can be done to electronic components if touched by a user who is electrostatically charged.

Instructions for Use

Read and follow the IFUs packaged with the ICP Monitor and patient bedside monitors before connecting the Interface Cable. Select the Interface Cable that is compatible with the patient bedside monitor that will be used. Visually inspect the cable, connectors, and connector pins for signs of damage. Do not use if damaged. Make sure that the connector pins and internal portions of the connector are dry and free of visible debris prior to use. Connect the Interface Cable to the appropriate ICP Monitor and then to the patient bedside monitor.

Discontinue Monitoring/Removing Interface Cable 1.

2.

3.

To disconnect the Interface Cable from the ICP Monitor, grasp the outer connector locking ring and gently pull backwards towards the strain relief to release the mechanical lock. The Interface Cable should pull out of the connector freely. Wipe down the Interface Cable with either of the following: a. Combination wipes (Quaternary a. Ammonium/Isopropyl Alcohol) b. 70% Isopropyl Alcohol CAUTION: Do not immerse the cable in any liquid or allow liquid to enter the connector. Visually inspect the Interface Cable after each use for the following conditions: a. Cracked or damaged cable insulation or conductors b. Damaged connectors; connector pins that are bent or broken CAUTION: Do not use an Interface Cable with any of the conditions listed above or if additional issues that might affect the function of the cable are identified. Contact your sales representative for a replacement. CAUTION: Do not sterilize the Interface Cable. Damage will result.

Storage

For long-term storage of the interface cable, ensure that it is protected from dust and kept in a clean, dry environment with these conditions: • Humidity (RH) range: 15% to 85% (non-condensing) • Temperature range: 0°C to +50°C

Service and Repair

The Interface Cable is not a repairable product; please contact your local sales representative to order a replacement.

Product Lifetime

Visually inspect the Interface Cable before each use for the following: • Replace the Interface Cable if there is any sign of deterioration such as broken insulation or frayed wires. • Connectors are undamaged; connector pins are not bent. • If the Interface Cable does not comply with these conditions or has any other problems that might affect function, do not use the Interface Cable.

Product End of Life

The cable contains electrical components. Dispose of the equipment in accordance with local ordinances.

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Integra LifeSciences Switzerland Sarl Rue Girardet 29 (2nd Floor) Le Locle Neuchatel CH-2400, Switzerland

Integra LifeSciences Services Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest – France Tel: 33 (0) 4 37 47 59 10

Codman, DirectLink, Integra, and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. CereLink is a trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2021 Integra LifeSciences Corporation. All rights reserved. LCN 208541-001 Rev E 2021-01 1064048-3